Anderson, R.T., Kimmick, G.G., McCoy, T.P., Hopkins, J., Levine, E., Miller, G., . . . Mihalko, S.L. (2012). A randomized trial of exercise on well-being and function following breast cancer surgery: The RESTORE Trial. Journal of Cancer Survivorship: Research and Practice, 6(2), 172–181.

DOI Link

Study Purpose

To determine the effectiveness of early exercise intervention programs on the quality of life, physical function, and arm volume for breast cancer survivors immediately following breast cancer surgery

Intervention Characteristics/Basic Study Process

Participants were randomized into a control group and an intervention group. The control group received patient education only (tips about lymphedema awareness and prevention exercises from a general newsletter). The intervention group underwent a tailored comprehensive program (the RESTORE program), which consisted of a structured exercise regimen, a lymphedema prevention module, patient and diet education, and counseling sessions. The intervention occurred every 3 months, beginning from 4–12 weeks after breast cancer treatment. The final session occurred at 18 months.

Sample Characteristics

  • The sample (N = 82) was comprised of female patients.
  • Mean age was 53.6 years with a range of 32–82 years.
  • Patients were within 4–12 weeks of surgery and had stage I–III breast cancer.
  • Of the sample, 46% had breast-conserving surgery, 79% had axillary node dissection, 59% received chemotherapy, 64% received radiation, and 71% had a mass body index of equal or greater than 25 kg/m2.

Setting

The study took place across multiple in-patient and home settings in association with Wake Forest University Health Center.

Phase of Care and Clinical Applications

Patients were undergoing transition from breast cancer treatment to active treatment for lymphedema.

Study Design

The study used a single, blinded, randomized controlled design.

Measurement Instruments/Methods

The effectiveness of the RESTORE program was measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B), distance traveled during a six-minute walk (measured by a pedometer), and arm volumes measured at three-month intervals using the water displacement method. The FACT-B was a survey that assessed physical, social, and functional well-being of the participants.

Results

Those in the exercise intervention had a significantly higher distances walked in the six-minute walk test than in the control group by the end of all the study (p = 0.00098). However, there was no statistical difference between the average FACT-B scores from the control and intervention groups. (p = 0.57). There also was no statistical significance between groups in terms of arm volume when compared with measurements at baseline and 18 months (p = 0.54).

Conclusions

There appears to be a positive correlation between the RESTORE program and physical function in individuals immediately after breast cancer treatment. Unexpectedly, this did not translate into a decrease in lymphedema-related symptoms (like edema) or social perceptions of the disease.

Limitations

  • The sample was small (N < 100).
  • The intervention was expensive, impractical, or required extensive training for a long period of time.
  • Subject withdrawals were greater than or equal to 10%.

Nursing Implications

Nurses should be aware of the symptoms that patients can present with after breast cancer remission. Nurses should encourage their patients to seek regular visits to their healthcare providers because this study showed that physical function can improve with more vigorous self-maintenance and early intervention. Further research should be conducted to determine the effectiveness of the RESTORE program as a standalone therapy.